A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
| Registry | NCT06868186 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 204 (Estimated) |
| Sponsor | Hutom Corp (Industry); collaborators: Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Kyungpook National University Hospital, Severance Hospital |
| Conditions | Renal Tumors |
| Interventions | RUS NE (Device) |
| Dates | start 2025-04-29, primary completion 2025-08-29, completion 2026-04-30 (estimated), first posted 2025-03-10, last updated 2025-09-11 |
| Locations | 4 sites in South Korea |
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All trials for Renal Tumors All trials of RUS NE
This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.
* Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software)
* Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants
After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental Group | Experimental | Device: RUS NE | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE. |
| Control arm | No intervention | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE. |
Sex: All, ages: 19 Years to 80 Years
Inclusion Criteria: * Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy * The diameter of renal tumor is 7cm or below * Individuals aged between 19 and 80 * Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form Exclusion Criteria: * Individuals with solitary kidney or horseshoe kidney * Individuals undergo bilateral nephrectomy * Individuals undergo operation other than partial nephrecotmy * Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes * Individuals with severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation) * Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI * Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study * Individuals who were participated in other clinical study within 4 weeks of screening * Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators
| Facility | City | Country | Status |
|---|---|---|---|
| Chonnam National University Hospital | Kwangju, Jeollanam-do | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Severance Hospital | Seoul | South Korea | Recruiting |